(149 days)
Not Found
No
The summary describes a device that acquires, processes, and stores physiological data, but there is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "monitoring system" that "acquires, processes and stores information regarding" physiological parameters. It collects data and sends it to a monitor for display. There is no mention of it treating, preventing, or mitigating any disease or condition.
No.
The document states that the TRAM Module "acquires, processes and stores information regarding these parameters" (physiological data) and "collects a patient's physiological data and sends it to a GEMS IT bedside monitor for display." While it measures physiological parameters, there is no mention of it performing analysis or interpretation of this data to make a diagnosis. Its function is to monitor and transmit patient data.
No
The device description explicitly states that the TRAM Module is a "component of GE Medical Systems Information Technologies host monitoring systems" and "collects a patient's physiological data and sends it to a GEMS IT bedside monitor for display." This indicates it is a hardware module that interacts with other hardware components (bedside monitor) to acquire and process data, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The TRAM Module is described as a device that monitors physiological parameters directly from the patient's body (ECG, blood pressure, pulse oximetry, etc.). It acquires, processes, and stores this data for display on a bedside monitor.
- Lack of Specimen Analysis: There is no mention of the TRAM Module analyzing any biological specimens or samples taken from the patient. Its function is to measure and transmit real-time physiological signals.
Therefore, the TRAM Module falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system.
Physiological parameter data includes ECG, invasive blood pressure, noninvasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM Module acquires, processes and stores information regarding these parameters.
The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.
Product codes
MHX
Device Description
The TRAM Module is part of a multi-parameter modular system that measures and processes a patient's physiologic parameters. The TRAM Module works as a component of GE Medical Systems Information Technologies host monitoring systems and does not function on its own. The TRAM Module collects a patient's physiological data and sends it to a GEMS IT bedside monitor for display. TRAM modules incorporate different monitoring capabilities based on their configuration. The TRAM Module can also be used as a transport monitor when used with the Transport Remote Acquisition Module Patient Monitoring System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
licensed healthcare practitioner, or by personnel trained in its proper use.
professional medical facility, such as hospital, clinic, surgical center or doctor's office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Summary:
The TRAM Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the TRAM Module:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews .
- Testing on unit level (Module verification) ●
- . Integration testing (System verification)
- Final acceptance testing (Validation) +
- Performance testing .
- . Safety testing
- Environmental testing .
Conclusion:
The results of these measurements demonstrated that the TRAM Module are as safe, as effective, and perform as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K011000 GEMS-IT Transport Remote Acquisition Module (TRAM)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
05-3/21
Premarket Notification 510(k) Summary
As required by section 807.92
| Date: | February 1, 2006 | APR | 5 | 2006 | |
|---|---|---|---|---|---|
| Submitter: | GE Medical Systems Information Technologies | ||||
| 8200 West Tower Avenue | |||||
| Milwaukee, WI 53223 USA | |||||
| Contact Person: | Joel Kent | ||||
| GE Healthcare | |||||
| 86 Pilgrim Road | |||||
| Needham, MA 02492 USA | |||||
| Phone: (781) 449-8685 | |||||
| Fax: (781) 433-1344 | |||||
| Device: Trade Name: | TRAM Module | ||||
| Common/Usual Name: | Physiological Patient Monitor (Multi-parameter Module) | ||||
| Classification Names: | The following Class II classifications appear applicable: | ||||
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | |||||
| 21 CFR 870.1025 Monitor, Physiological, Patient (With | |||||
| Arrhythmia Detection Or Alarms) | |||||
| 21 CFR 868.2375 Breathing Frequency Monitor | |||||
| 21 CFR 870.1100 Monitor, Blood Pressure, Indwelling | |||||
| 21 CFR 870.1130 Noninvasive Blood Pressure Measurement | |||||
| System | |||||
| 21 CFR 870.1100 Blood Pressure Alarm | |||||
| 21 CFR 870.1425 Programmable Diagnostic Computer | |||||
| 21 CFR 870.1915 Probe, Thermodilution | |||||
| 21 CFR 870.2340 Electrocardiograph | |||||
| 21 CFR 880.2910 Monitor, Temperature (with probe) | |||||
| 21 CFR 870.2300 Monitor, Cardiac (Incl. Cardiotachometer & | |||||
| rate alarm) | |||||
| 21 CFR 870.2700 Oximeter, Pulse | |||||
| Predicate Devices: | K011000 GEMS-IT Transport Remote Acquisition Module | ||||
| (TRAM) |
1
Device Description: The TRAM Module is part of a multi-parameter modular system that measures and processes a patient's physiologic parameters. The TRAM Module works as a component of GE Medical Systems Information Technologies host monitoring systems and does not function on its own. The TRAM Module collects a patient's physiological data and sends it to a GEMS IT bedside monitor for display. TRAM modules incorporate different monitoring capabilities based on their configuration. The TRAM Module can also be used as a transport monitor when used with the Transport Remote Acquisition Module Patient Monitoring System.
Intended Use:
The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system Physiological parameter data includes ECG, invasive blood pressure, noninvasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.
Technology:
The TRAM Module employs the same functional scientific technology as its predicate devices.
2
Test Summary:
The TRAM Module and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the TRAM Module:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews .
- Testing on unit level (Module verification) ●
- . Integration testing (System verification)
- Final acceptance testing (Validation) +
- Performance testing .
- . Safety testing
- Environmental testing .
Conclusion:
The results of these measurements demonstrated that the TRAM Module are as safe, as effective, and perform as well as the predicate device.
3
Image /page/3/Picture/10 description: The image shows a circular logo with the words "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the outside. Inside the circle is a symbol that looks like three stylized birds in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2006 APR
GE Medical Systems Information Technologies c/o Mr. Joel Kent GE Healthcare 86 Pilgrim Road Needham, MA 02492
Re: K053121 Trade Name: TRAM Module Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-segment Measurement and Alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: February 10, 2006 Received: February 13, 2006
Dear Mr. Kent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Joel Kent
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhemmmon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K053121
Device Name: TRAM Module
Indications for Use:
The TRAM Module is intended for use under the direct supervision of a licensed The Treationer, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system.
Physiological parameter data includes ECG, invasive blood pressure, non-invasive ma I fryslorogical paramoter data merades output, temperature, and respiration. The TRAM Module acquires, processes and stores information regarding these parameters.
The device is intended for use in a professional medical facility, such as hospital, clinic, I he device is mentator's office. The TRAM System can be used in multiple areas such surgiour of Colors (OR), post anesthesia recovery (PARR), critical care, surgical as operating Toon. (ory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blymmumor
gn-Off)
Cardiovascular Devices
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